Clinical trial · Observational
Neoadjuvant Radiotherapy and Surgery for High-Risk Localized Ewing Sarcoma
An Observational Study on the Safety and Efficacy of Neoadjuvant Concurrent Chemoradiotherapy Sequential Surgery for High-Risk Localized Ewing Sarcoma
NCT07620431CI-TRIAL-00113256not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-center, single-arm, prospective observational study to evaluate the long-term local control rate, safety, and efficacy of preoperative neoadjuvant radiotherapy (36-45 Gy) followed by sequential radical surgery and postoperative chemotherapy in patients with high-risk, resectable localized Ewing sarcoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Neoplasms | Bone Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Local Recurrence-Free Survival (LRFS)
- timeFrame
- From the date of surgery up to the date of first documented local recurrence or death from any cause, assessed up to 5 years post-surgery.
- description
- Time from the date of surgery to the first documented local recurrence or death from any cause.
- measure
- Wound Healing Status
- timeFrame
- Postoperative week 2.
- description
- Evaluation of surgical wound healing grade (Grade A/B/C) according to clinical criteria.
- measure
- Surgical Margin Status
- timeFrame
- At the time of pathological evaluation, typically within 7 to 14 days post-surgery.
- description
- Pathological evaluation of margins (R0/R1/R2) and the distance to the closest margin.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Months
Show eligibility criteria text
Inclusion Criteria: 1. The subject or their legal representative signs the written informed consent prior to enrollment. 2. Age \<= 55 years old. 3. Histologically confirmed Ewing sarcoma, with FET family (including EWSR1 or FUS) gene rearrangement confirmed by FISH or NGS. Clear FET-non ETS fusion cases are excluded. 4. Deemed difficult to achieve a satisfactory surgical margin by 2 or more senior musculoskeletal oncologists. 5. ECOG Performance Status: 0-1. 6. Expected life expectancy \>= 3 months. 7. Women of childbearing potential must have a negative pregnancy test within 1 week prior to enrollment and agree to use contraception; male subjects must agree to use contraception or have undergone surgical sterilization during the study. Exclusion Criteria: 1. No opportunity for surgical resection after neoadjuvant chemotherapy. 2. Extensive metastasis with no indication for local surgical resection. 3. Uncontrolled concurrent medical conditions. 4. Prior radiotherapy to the surgical site during front-line treatment. 5. History of other malignant tumors within the past 5 years. 6. Inability to cooperate with preoperative neoadjuvant radiotherapy (e.g., due to psychiatric factors). 7. Any condition that, in the investigator's judgment, might harm the patient or prevent compliance with study requirements.
References
Publications (0)
Data not yet available
No reference posted for this study.